Saturday, May 26, 2018

Sesame Workshop asserts trademark violations in marketing of the movie "The Happytime Murders"


In a post titled Sesame Workshop Sues Over ‘Happytime Murders’ Trailer Featuring ‘Ejaculating Puppets’ , SFGate
discusses some of the story involved in a trademark/tarnishment lawsuit over the use of the word "Sesame" in a movie trailer
for the movie "The Happytime Murders."

The crux of the issue involves the marketing of the movie; from SFGate:


In a statement provided to TheWrap on Friday [25 May 2018], Sesame Workshop said that
they “take no issue with the creative freedom of the filmmakers and their right to make and promote this movie,
rather this is about how our name is being misused to market a film with which we have no association.”



Variety noted the following from the lawsuit:


" ‘Sesame’ is not trying to enjoin defendants’ promotion or distribution of their movie.
It is only defendants’ deliberate choice to invoke and commercially misappropriate ‘Sesame’s’ name and goodwill
in marketing the movie — and thereby cause consumers to conclude that ‘Sesame’
is somehow associated with the movie — that has infringed on and tarnished the ‘Sesame Street’ mark and goodwill.”

Filed in New York [on 24 May 2018], the lawsuit also contains screen captures of social media reactions.
One tweet read, “I’ll never look at muppets/sesame street the same way.”
According to the suit, Sesame Workshop, the nonprofit behind the television show,
sent a letter on May 18 to in-house counsel of STX and the Jim Henson Company,
which is a producer on the film, demanding they stop making references to “Sesame Street” in the marketing materials.



[emphasis added. from ‘Sesame Street’ Creators Sue STX Entertainment Over Marketing for ‘The Happytime Murders’ ]


***
Separately, from blawgsearch on 26 May 2018


Friday, May 25, 2018

CAFC in Viatech v. Microsoft: a collection of files is a file, but no argument by footnore



The CAFC found D. Delaware erred in claim construction:


We agree with ViaTech that the district court’s construction
of “dynamic license database” is unsupported by
the ’567 patent specification. The district court construed
the term to mean “a database that resides in the digital
content file and that is programmed to accept modifiable
licenses.” ViaTech Tech. Inc., 2016 WL 3398025, at *5.

(...)

Microsoft argues that the preamble language of
Claims 1, 28 and 31, “comprising,” “containing,” and
“including” respectively, require that all the subsequent
recited claim elements “reside in” the claimed “digital
content file.” We do not agree. Doing so would render the
“embedded in” and “associated with” language in those
claims superfluous, and a “claim construction that gives
meaning to all the terms of the claim is preferred over one
that does not do so.” Merck & Co. v. Teva Pharm. USA,
Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005); see also In re
Power Integrations, Inc., 884 F.3d at 1376. In the context
of claim 1, the better reading of the final paragraph
relating to the “the dynamic license database” is that it
recites the required functional relationship between the
database and the digital content file, not that the database
necessarily resides in the digital content file.
We also do not agree with the district court’s conclusion
that “dynamic” in “dynamic license database” defines
the license rather than the database.



And, of the meaning of "file"


The district court construed file as “a collection of data
that is treated as a unit by a file system.” ViaTech
Tech. Inc., 2016 WL 3398025, at *6. The district court
then applied the construction to Microsoft Windows and
found that pre-installation, the disk image file version of
Windows is a “file,” but that post-installation, “Windows
is a collection of files, not a single file.” ViaTech Tech.
Inc., 2017 WL 2538570, at *5.
We do not agree that a collection of files cannot be a
“file” under the district court’s construction.

(...)

Both ViaTech and Microsoft agree that such “container
files” can be a “file” as the term is used in the ’567
patent. Appx2501–02 (Microsoft Expert Testimony);
Appx1172 (ViaTech Expert Testimony); Oral Arg. 23:59–
24:26 (Microsoft’s admission during appellate argument).
Microsoft’s expert’s analogy is illustrative: a large box
with smaller boxes in it would still be considered a single
package. Appx2502. Similarly, a file with multiple files
within it can still be “a collection of data treated as a unit
by a file system.”
This understanding of “file” does not require changing
the district court’s construction, only its application of
that construction. Thus, we uphold the district court’s
construction, but clarify that a “file” as claimed in the ’567
patent may be a collection of files.



BUT


A district court’s grant of summary judgment is reviewed
in accordance with the law of the regional circuit.
Profectus Tech. LLC v. Huawei Techs. Co., 823 F.3d 1375,
1379 (Fed. Cir. 2016). The District of Delaware is in the
Third Circuit, which reviews a grant of summary judgment
de novo. Chimie v. PPG Indus., Inc., 402 F.3d 1371,
1376 (Fed. Cir. 2005). Here, Microsoft is “entitled to a
judgment as a matter of law” if ViaTech, as the party with
the burden of proving infringement, “has failed to make a
sufficient showing on an essential element of [its] case
with respect to which [it] has the burden of proof.” Celotex
Corp. v. Catrett, 477 U.S. 317, 323 (1986).
Despite changing the construction of “dynamic license
database” and clarifying the district court’s construction
of “file” above, we find that these modifications do not
affect the reasoning or outcome of the district court’s
summary judgment order.



As to "argument by footnote"


Arguments that were not properly presented to the
district court are waived on appeal. Sage Prods., Inc. v.
Devon Indus., Inc., 126 F.3d 1420, 1426 (Fed. Cir. 1997).
As a threshold matter, a single footnote is insufficient to
present a distinct infringement theory to the district
court. See SmithKline Beecham Corp. v. Apotex Corp.,
439 F.3d 1312, 1320 (Fed. Cir. 2006). Here, the footnote
did not even present a distinct alternative infringement
theory: there is no element by element analysis of a postinstallation
version of Windows, or even a statement that
the post-installation version is a file that infringes the
’567 patent too. And regarding the four unquoted, uncited
paragraphs of ViaTech’s 147 paragraph expert report,
ViaTech agrees that the district court was not obligated to
address theories presented in an expert report when the
theories were not raised or cited in briefing before the
court. Oral Arg. 13:04–13:58; see also Pandrol USA, LP v.
Airboss Ry. Prod., Inc., 320 F.3d 1354, 1366 (Fed. Cir.
2003) (“There is no onus on the district court to distill any
possible argument which could be made based on the
materials before the court. Presenting such arguments in
opposition to a motion for summary judgment is the
responsibility of the non-moving party, not the court.”)
(citation omitted).

Pro se appellant Jerry Artrip fails at CAFC



The outcome:


Jerry Artrip appeals the district court’s dismissal of
his case. Mr. Artrip asks us to reverse the district court
and remand so that he may file a fourth amended complaint
charging Appellees Alcoa, Inc. (“Alcoa”), Ball Corp.,
and Ball Metal Beverage Container Corp. (together,
“Ball”) with patent infringement.

We lack jurisdiction to review the dismissal of Mr. Artrip’s
claims against Alcoa. And because we find that
Mr. Artrip’s third amended complaint does not satisfy the
legal pleading standard and that the district court did not
abuse its discretion in denying leave for further amendments,
we affirm the district court’s dismissal of
Mr. Artrip’s claims against Ball with prejudice.



The problem


We have jurisdiction only if Mr. Artrip filed a timely
notice of appeal that complies with Rule 3 of the Federal
Rules of Appellate Procedure. See Smith v. Barry,
502 U.S. 244, 248–49 (1992) (“Rule 3’s dictates are jurisdictional
in nature, and their satisfaction is a prerequisite
to appellate review.”).

(...)

Among other requirements, Rule 3 states that a notice
of appeal must “designate the judgment, order, or part
thereof being appealed.” Int’l Rectifier Corp. v. IXYS
Corp., 515 F.3d 1353, 1357 (Fed. Cir. 2008) (emphasis
added) (quoting Fed. R. App. P. 3(c)(1)); see also Durango
Assocs., Inc. v. Reflange, Inc., 912 F.2d 1423, 1425
(Fed. Cir. 1990) (finding party “cannot now expand the
scope of its specifically limited notice of appeal”). Our
sister circuits have found that they do not have jurisdiction
to review orders other than those identified in the
notice of appeal. See, e.g., Doran v. J.P. Noonan Trans.,
Inc., 853 F.3d 66, 69 (1st Cir. 2017) (finding “no basis to
reverse an order” other than order designated in notice);
In re GNC Corp., 789 F.3d 505, 512 (4th Cir. 2015) (dismissing
appeal as to order not identified in notice); Stephens
v. Jessup, 793 F.3d 941, 943 (8th Cir. 2015) (finding
no jurisdiction to review order dismissing first party
where notice of appeal identified separate order only
dismissing second party).
Here, Mr. Artrip’s notice of appeal identifies only the
district court’s November 3, 2017 order dismissing the
third amended complaint against Ball. Alcoa is mentioned
only in the notice’s case caption. Although we
construe notices of appeal liberally, Mr. Artrip’s notice
does not indicate an intent to appeal the district court’s
earlier order dismissing the second amended complaint
and terminating Alcoa. See Smith, 502 U.S. at 248 (permitting
courts to find compliance “‘with the rule if the
litigant’s action is the functional equivalent of what the
rule requires’” but explaining “[t]his principle of liberal
construction does not, however, excuse noncompliance
with the Rule. Rule 3’s dictates are jurisdictional” (quoting
Torres v. Oakland Scavenger Co., 487 U.S. 312, 317
(1988))).

The Trump FDA publishes list of Reference Listed Drug (RLD) Access Inquiries


The FDA has posted a list of 50 drugs for which there have been Reference Listed Drug (RLD) Access Inquiries, of which two drugs (Ampyra and Tecfidera) have relation to multiple sclerosis.

This particular issue relates to samples needed by a potential generic maker to show, through testing, that its generic product is
bioequivalent to the proprietary drug [also termed the reference listed drug (RLD) ]. As the FDA notes


To obtain approval for a generic drug, the generic company needs to show, among other things, that its version of the product is bioequivalent to the RLD. This usually requires the generic company to conduct bioequivalence studies comparing its product to the RLD, and to retain samples of the RLD used in testing after a study is complete. To conduct these kinds of bioequivalence studies, the generic company needs to obtain samples (generally between 1,500 and 5,000 units) of the RLD.



The list of 50 drugs published by the FDA relates to instances in which the generic company has had difficulties obtaining the
samples needed for testing. The FDA notes


At times, certain “gaming” tactics have been used to delay generic competition. One example of such gaming is when potential generic applicants are prevented from obtaining samples of certain brand products necessary to support approval of a generic drug. The inability of generic companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process – leading to delays in bringing affordable generic alternatives to patients in need.

As described in further detail below, these kinds of problems with generic access to necessary samples may occur when brand products are subject to limited distribution – whether the company has voluntarily adopted limitations on distribution, or the limitations have been imposed in connection with a Risk Evaluation and Mitigation Strategy (or REMS), a program that FDA implements for certain drugs to help ensure that their benefits outweigh their risks. In some cases, brand drug sponsors may use these limited distribution arrangements, whether or not they are REMS-related, as a basis for blocking potential generic applicants from accessing the samples they need.



Neither Ampyra nor Tecfidera are stated to have a REMS issue.


See also the post from multiplesclerosisnewstoday
Two MS Medications Appear on FDA’s Shame List

Note also activities of Kyle Bass related to Ampyra and Tecfidera


The IPR petitions of Kyle Bass on Acorda/Ampyra denied by PTAB



A tale of two tribunals. Four Acorda multiple sclerosis patents go from --not invalid-- to invalid in less than one month!



PTAB declines to institute IPR against Biogen's US 8,399,514 related to the MS drug Tecfidera



Kyle Bass loses challenge to MS drug Tecfidera on US Patent 8,399,514 in IPR2015-01993


One might speculate that the Obama administration wss more "big pharma friendly" than is the Trump administration.

Thursday, May 24, 2018

CAFC tackles estoppel, royalty rate in XY v. Trans Ova


The outcome in XY vs Trans Ova :


We affirm in part, vacate in part, and remand. Two
issues presented on appeal are moot. With respect to the
remaining issues, we affirm on all issues except the
district court’s ongoing royalty rate, which we vacate. We
remand for the district court to recalculate an ongoing
royalty rate in accordance with this opinion.



Note:


We do not find, as the Dissent states, that “in the
event of conflict the administrative agency’s decision
‘moots’ the district court’s decision.” Dissent at 6. Rather,
we find that an affirmance of an invalidity finding,
whether from a district court or the Board, has a collateral
estoppel effect on all pending or co-pending actions.
This court has long applied the Supreme Court’s holding
in Blonder-Tongue to apply collateral estoppel in mooting
pending district court findings of no invalidity based on
intervening final decisions of patent invalidity. See, e.g.,
Mendenhall v. Barber-Greene Co., 26 F.3d 1573, 1576
(Fed. Cir. 1994); Dana Corp. v. NOK, Inc., 882 F.2d 505,
507–08 (Fed. Cir. 1989). This court also recently applied
the Supreme Court’s holding in B&B Hardware, Inc. v.
Hargis Industries, Inc., 135 S. Ct. 1293, 1303 (2015), to
apply such estoppel to Board decisions. See MaxLinear,
Inc. v. CF CRESPE LLC, 880 F.3d 1373 (Fed. Cir. 2018)
The instant case is a straightforward application of this
court’s and Supreme Court precedent.

As to the Dissent’s concern of applying estoppel without
briefing, both precedent and the parties’ positions
allow application of collateral estoppel sua sponte here. A
remand for briefing is not a requirement to applying
estoppel when there is no indication from the Patent
Owner that “it did not have a full and fair opportunity to
litigate the validity” of its patent in the parallel case.
Dana Corp., 882 F.2d at 508. Here, in oral argument,
both parties assumed that an affirmance of the Board’s
decision would result in estoppel and thus simply disputed
the result of such estoppel. Trans Ova argued that an
affirmance would call for a remand of this case to reassess
damages in light of the Freezing Patent’s invalidity,
while XY argued that an affirmance would not require
a remand because the asserted patents were grouped in a
way where the invalidation of one patent would not affect
the damages award. Oral Arg. at 1:30–46, 18:10–19:20.
There is no indication that either party thought estoppel
would not apply. Thus, this court, in circumstances such
as this one, applies estoppel sua sponte to avoid “unnecessary
judicial waste” from remanding an issue that has a
clear estoppel effect. Arizona v. California, 530 U.S. 392,
412 (2000).



Of royalty:


XY points out that, if we were to affirm the result in
this case, it would result in the “absurd practical result
. . . that XY would have been better off forgoing the
12.5% ongoing royalty and suing Trans Ova repeatedly for
future infringement at the jury’s 15% reasonable royalty
rate.” XY Reply Br. at 13. Assuming no changed circumstances
exist (either good or bad for XY) between the date
of first infringement and the date of the jury’s verdict, we
agree with XY that allowing the district court’s ongoing
rates to stand in this case would create an odd situation.
Although district courts may award a lower ongoing
royalty rate if economic factors have changed in the
infringer’s favor post-verdict—for example, if a newlydeveloped
non-infringing alternative takes market share
from the patented products—the district court identified
no economic factors that would justify the imposition of
rates that were lower than the jury’s.1

CAFC affirms D. Delaware in UCB case by 2-1 vote


The CAFC affirmed D. Delaware in the UCB case:


Following a bench trial, the district court made exhaustive
fact findings based on the trial evidence and
concluded that the asserted claims of the ’551 patent are
not invalid. Appellants appeal that decision, arguing that
the district court misapplied the legal standards for
obviousness-type double patenting, obviousness, and
anticipation, and that the prior art anticipates and/or
renders the ’551 patent obvious.
As explained more fully below, we hold that the district
court applied the correct legal standards in its obviousness-type
double patenting, obviousness, and
anticipation analyses. And because we discern no clear
error in its underlying fact findings, we affirm the district
court’s ultimate conclusion that the asserted claims are
not invalid.



Of obviousness-type double patenting:


By statute, only a single patent may issue for the
same invention. See 35 U.S.C. § 101 (“Whoever invents or
discovers any new and useful process, machine, manufacture,
or composition of matter, or any new and useful
improvement thereof, may obtain a patent therefor . . . .”)
(emphasis added); In re Lonardo, 119 F.3d 960, 965
(Fed. Cir. 1997) (“[Section 101] thus permits only one
patent to be obtained for a single invention, and the
phrase ‘same invention’ refers to an invention drawn to
substantially identical subject matter.”).
Nonstatutory double patenting, however, is a judicially-created
doctrine, which “prohibits an inventor from
obtaining a second patent for claims that are not patentably
distinct from the claims of the first patent.” Id. at
965. It “prevent[s] the extension of the term of a patent,
even where an express statutory basis for the rejection is
missing, by prohibiting the issuance of the claims in a
second patent not patentably distinct from the claims of
the first patent.” Otsuka Pharm. Co. v. Sandoz, Inc.,
678 F.3d 1280, 1297 (Fed. Cir. 2012) (quoting In re Longi,
759 F.2d 887, 892 (Fed. Cir. 1985)) (alteration in original).
The obviousness-type double patenting analysis involves
two steps: “First, the court ‘construes the claim[s]
in the earlier patent and the claim[s] in the later patent
and determines the differences.’ Second, the court ‘determines
whether those differences render the claims
patentably distinct.’” AbbVie Inc. v. Mathilda & Terence
Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1374
(Fed. Cir. 2014) (quoting Sun Pharm. Indus., Ltd. v. Eli
Lilly & Co., 611 F.3d 1381, 1385 (Fed. Cir. 2010)). The
second part of this analysis is analogous to the obviousness
inquiry under 35 U.S.C. § 103 in the sense that if an
earlier claim renders obvious or anticipates a later claim,
the later claim is not patentably distinct and is thus
invalid for obviousness-type double patenting. Id.
at 1378–79. In chemical cases, the double patenting
inquiry is not whether a person of ordinary skill in the art
would select the earlier compound as a lead compound,
but rather whether the later compound would have been
an obvious or anticipated modification of the earlier
compound. Otsuka, 678 F.3d at 1297. Unlike in an
obviousness analysis, the underlying patent in the double
patenting analysis need not be prior art to the later claim.
See id.

(...)

We agree with Appellants that the obviousness-type
double patenting inquiry requires consideration of the
differences between the claims in the reference
’301 patent and the ’551 patent. As we stated above, the
focus of the double patenting analysis entails determining
the differences between the compounds claimed in the
reference and asserted patents and then “determin[ing]
whether those differences render the claims patentably
distinct.” AbbVie, 764 F.3d at 1374 (emphasis added). In
this case, both claims recite a methoxymethyl group at R3.
Thus, the double patenting analysis requires determining
whether the claims’ differences, i.e., unsubstituted benzyl
and methyl at R and R1, would have been obvious to one
of skill in the art.

(...)

We turn next to the district court’s double patenting
analysis. Appellants assert that claims 9, 10, and 13 of
the ’551 patent are not patentably distinct from claims
44–47 of the ’301 patent and are thus invalid for obviousness-type
double patenting. Because these claims only
have a common methoxymethyl group at the R3 position,
the question before us is whether a person of ordinary
skill in the art, starting with claim 45 of the ’301 patent,
would have been motivated to place an unsubstituted
benzyl at R and an unsubstituted methyl at R1 in combination
with the methoxymethyl group at R3 with a reasonable
expectation of success. We acknowledge that this
is a close case, but because we discern no clear error in
the district court’s underlying fact finding that there
would have been no reasonable expectation of success in
placing an unsubstituted benzyl and methyl in the
claimed combination, we agree with the district court that
the asserted claims of the ’551 patent are patentably
distinct from the ’301 patent.

(...)

Here, the district court, relying on the prior
art and expert evidence, found no reasonable expectation
of success. That is a fact finding that we review for clear
error following a bench trial. Par Pharm., Inc. v. TWI
Pharm., Inc., 773 F.3d 1186, 1196 (Fed. Cir. 2014).


Of enantiomers:


We hold that the district court did not clearly err in
finding that LeGall does not anticipate claim 9 of the
’551 patent. As the district court recognized, we have
held that “[t]he knowledge that enantiomers may be
separated is not ‘anticipation’ of a specific enantiomer
that has not been separated, identified, and characterized.”
Id. at 1084.



In her dissent, CJ Prost writes


An obviousness
determination requires that a skilled artisan would have
perceived a reasonable expectation of success in making
the invention in light of the prior art. Id. at 1362. This is
a question of fact, which we review for clear error following
a bench trial. Par Pharm., Inc. v. TWI Pharm., Inc.,
773 F.3d 1186, 1198 (Fed. Cir. 2014). “A factual finding is
clearly erroneous if, despite some supporting evidence,
‘the reviewing court on the entire evidence is left with the
definite and firm conviction that a mistake has been
committed.’” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348,
1359 (Fed. Cir. 2007) (quoting United States v. U.S.
Gypsum Co., 333 U.S. 364, 395 (1948)).

(...)

While it is true that there may be some evidence
supporting the district court’s view, given the overwhelming
evidence to the contrary, I am “left with the definite
and firm conviction that a mistake has been committed.”
Pfizer, 480 F.3d at 1359 (quoting U.S. Gypsum, 333 U.S.
at 395).

(...)

It was clear error for the district court to require testing
to provide “insight into the effectiveness of benzyl and
methyl relative to other structures that could be placed at
R and R1.” Id. Where the prior art teaches that the
selected substituent will work, even when it is selected
from thousands of compounds, an inability to predict how
any one substituent will work in the composition and a
need for testing will not render that selection nonobvious.
See In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985)
(“Although [the inventor] declared that it cannot be
predicted how any candidate will work in a detergent
composition, but that it must be tested, this does not
overcome [the prior art’s] teaching that hydrated zeolites
will work.”); Pfizer, 480 F.3d at 1364.


Famous quotations that never were said


About ten years ago, in May 2008, IPBiz in the post
The urban legend of the Duell quote continues
the fake quote attributed to
Charles H. Duell:

Everything that can be invented has been invented

was debunked.

This quote had infiltrated a number of otherwise reliable sources
[ the Patently-O blog as well as in Joseph Hosteny's article in the May 2005 issue of Intellectual Property Today (pp. 28-29) ]
See
"Wrong expert prediction" site starts with fake quote of Duell


Recently, someone emailed me a quote attributed to Abraham Lincoln:


“I have two great enemies, the Southern Army in front of me, and the financial institutions in the rear. Of the two, the one in my rear is my greatest foe.”



On the internet, this is stated to be from a statement to Congress in 1865.

Of a different version of this concept, Snopes writes



Abraham Lincoln said:As a result of the war, corporations have been enthroned, and an era of corruption in high places will follow, and the money power of the country will endeavor to prolong its reign by working on the prejudices of the people until all wealth is aggregated in a few hands, and the republic is destroyed. I feel at this moment more anxiety for the safety of my country than ever before even in the midst of war. God grant that my suspicions may prove groundless.

These words did not originate with Abraham Lincoln, however — they appear in none of his collected writings or speeches, and they did not surface until more than twenty years after his death (and were immediately denounced as a “bold, unflushing forgery” by John Nicolay, Lincoln’s private secretary). This spurious Lincoln warning gained currency during the 1896 presidential election season (when economic policy, particularly the USA’s adherence to the gold standard, was the major campaign issue), and ever since then it has been cited and quoted by innumerable journalists, clergymen, congressmen, and compilers of encyclopedias.

Pedigree for this quote is often asserted by pointing to the 1950 Lincoln Encyclopedia, compiled by Archer H. Shaw, which “authenticates” the quote by citing a purported 1864 letter from Lincoln to one Col. William F. Elkins found in Emanuel Hertz’s 1931 book, Abraham Lincoln: A New Portrait.However, this source is fraudulent: the Elkins letter reproduced by Hertz was a forgery, and Shaw, a sloppy compiler, added the bogus letter to his encyclopedia


BUT see Truth or Fiction .

The text is from a purported letter to William F. Elkins dated November 21, 1864.

Whether in late 1864 or in 1865, neither the Southern army nor the banks were much of an enemy to Lincoln. Much effort was placed on securing passage of the 13th Amendment in the House.

Of the financing of the Civil War, see The High Cost of War in Barron's:
https://www.barrons.com/articles/SB50001424052970203990104576191061207786514?tesla=y

It is difficult to track down quotations attributed to people no longer living.
However, even among the living, myths propagate.
See

Things that weren't actually said, but became myths

Friday, May 18, 2018

Endo mainly prevails at CAFC in case related to painkiller opioid oxymorphone



The result of this Hatch-Waxman case was mainly a victory for the patent holder Endo:


The generic drug manufacturers argued generally that
the asserted patents’ claims were invalid or not infringed.
The district court rejected those arguments and found all
asserted claims of the ’122 and ’216 patents not invalid,
and all but two asserted claims infringed. Because there
is no reversible error in the district court’s findings, we
affirm.



Of details of the district court decision:


The district court concluded that the generic drug
manufacturers failed to show that the asserted claims of
the two patents are invalid. J.A. 128–29. Specifically, the
court found that the asserted claims of the two patents
are not invalid for obviousness; that the asserted claims
with the dissolution limitations are not invalid for lack of
written description; and that the asserted claims reciting
the multiple peaks limitations are not invalid for indefiniteness.
The court also found that Endo carried its
burden to show that defendants infringe or will infringe
all but two of the asserted claims of the ’122 and ’216
patents. J.A. 72–73. The court then issued a permanent
injunction against Actavis’s manufacture, use, offer to
sell, or sale of its generic version of OPANA®ER prior to
the expiration of the ’122 and ’216 patents. J.A. 182.



Of teaching away:


Amneal contends that the court erred by finding that
oxymorphone’s low bioavailability teaches away from
attempting a controlled release formulation. Overwhelming
evidence at trial, however, supports that factual
finding. Expert testimony showed that a skilled artisan
would not have been motivated to select oxymorphone for
use in a controlled release setting because of its “exceptionally
low bioavailability.” J.A. 98. As the district court
noted, the Oshlack reference also taught that “bioavailability
is a significant, even crucial, factor in evaluating a
drug’s suitability for placement in a controlled release
vehicle.” J.A. 92. The court also observed that “[t]he
notion that low-bioavailability drugs were considered
unsuitable for extended-release formulation is reinforced
by the fact that, until Endo’s development of OPANA®ER,
there were remarkably few such examples.” J.A. 94. For
example, the existence of another low-bioavailability
drug, oxybutynin—a non-opioid analgesic, unlike oxymorphone—which
had previously been developed into a
controlled release formulation, served to underscore “the
fact that low bioavailability drugs were remarkably rare
in controlled-release settings.” J.A. 95. Indeed, “its total
absence from the expert reports of both sides, impressed
on the court that low-bioavailability drugs were, at the
time of the invention, perceived as unsuited for development
into controlled release forms.” Id. Tellingly, Appellants’
own expert maintained the view that active
ingredients with poor bioavailability would not be good
candidates for controlled release dose forms. J.A. 2769.
Appellants contend that the low bioavailability of oxymorphone
could be addressed by increasing the dosage.
The district court did not err in rejecting that argument.
The court found, based on published research, that such
an approach “risk[ed] toxicity.”

(...)

Oxymorphone’s inclusion in Maloney’s and Oshlack’s
lists of candidate molecules does not alter this conclusion.
Those lists mention oxymorphone among a vast number of
other molecules, including drugs such as heroin, opium,
and fentanyl, so the district court doubted that the lists
would be taken seriously as indicating suitability for
controlled release treatment. J.A. 96–98. The court
noted, for example, that fentanyl was widely understood
as suitable only for transdermal, not oral, delivery. J.A.
96–97. Given that context, the district court reasonably
found that a skilled artisan would not have viewed oxymorphone
as suitable for a controlled release setting.
Moreover, neither Penwest S-1 nor Cleary discloses any
technical details, such as dosing interval or twelve-hour
efficacy, for achieving the claimed inventions. J.A. 3144–
45. Accordingly, a person of ordinary skill, upon reading
those references, would have been strongly discouraged
from using oxymorphone in a controlled release setting.
The district court did not clearly err in finding that the
references taught away from the claimed invention.


Of written description


The written description requirement provides that a
patentee’s application for a patent must “clearly allow
persons of ordinary skill in the art to recognize that [he]
invented what is claimed.” Ariad Pharm., Inc. v. Eli Lilly
& Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc)
(quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563
(Fed. Cir. 1991)). “[T]he test for sufficiency is whether the
disclosure of the application relied upon reasonably
conveys to those skilled in the art that the inventor had
possession of the claimed subject matter as of the filing
date.” Id.



Of injunction and irreparable harm:


Endo relatedly demonstrated, mainly through trial
testimony, that it had to lay off its sales force, which may
damage its reputation in the market segment and make
the company less attractive to potential new hires. The
court found that such irreparable harm cannot be adequately
addressed without an injunction.

Anacor loses in appeal of result of IPR decision coming from petition of Coalition for Affordable Drugs





In 2015, the Coalition for Affordable Drugs X LLC
filed a petition requesting inter partes review of all 12
claims of the ’621 patent. The Board instituted review
and found that the claims would have been obvious in
light of the combination of Int’l Pat. Appl. No.
PCT/GB95/01206 (“Austin”) and U.S. Pat. Appl. No.
10/077,521 (“Brehove”). Both Austin and Brehove teach
the use of boron heterocycles as antifungal agents that
inhibit C. albicans, among other fungi. Boron heterocy-
cles are organic compounds that contain both boron and
carbon in a ring structure.2
Austin teaches the use of oxaboroles—boron heterocycles
that include a five-member ring containing three
carbon atoms, one oxygen atom, and one boron atom—as
fungicides. Austin discloses tavaborole as one of a small
group of oxaboroles that were tested for antifungal activity
and teaches that tavaborole is a highly effective agent
that inhibits a variety of fungi, including C. albicans.



Footnote 4:


Dr. Stephen Kahl, another of the petitioner’s experts,
testified to the same effect. He stated, “I think a
[person of ordinary skill] would presume that if a compound
showed significant antifungal activity against any
of a variety of fungi, would have reasonable reason to look
at those against a specific fungus and expect some success.
. . . [F]ungi are rather simple organisms. And it’s
not unusual that a compound that . . . has antifungal
activity in one fungus, might be expected or at least
evaluated in another fungus.”




Of Anacor's arguments:



On appeal, Anacor first argues that the Board violated
due process and the procedural requirements of the
Administrative Procedure Act (“APA”) by failing to provide
Anacor with adequate notice of, and an opportunity
to respond to, the grounds of rejection ultimately adopted
by the Board.
Under the APA, a patent owner involved in an inter
partes review is entitled to notice of and a fair opportunity
to address the grounds of rejection. 5 U.S.C. §§ 554(b)–
(c), 557(c); Dell Inc. v. Acceleron, LLC, 818 F.3d 1293,
1301 (Fed. Cir. 2016). Therefore, an agency “may not
change theories in midstream without giving respondents
reasonable notice of the change and the opportunity to
present argument under the new theory.” Genzyme
Therapeutic Prod. Ltd. P’ship v. Biomarin Pharm. Inc.,
825 F.3d 1360, 1366 (Fed. Cir. 2016) (quoting Belden Inc.
v. Berk-Tek LLC, 805 F.3d 1064, 1080 (Fed. Cir. 2015)).

Anacor argues that the Board’s decision violated the
APA and due process in two related ways. First, Anacor
contends that the petitioner abandoned one prior art
reference in its reply (Brehove) and shifted to a new
theory of invalidity (relying on Austin in light of Segal
and Mertin), and that the Board adopted that new theory
without giving Anacor proper notice or an opportunity to
respond to it. Second, Anacor argues that, in bolstering
this new theory of obviousness, the petitioner impermissibly
relied on new evidence, not included in the petition, to
satisfy its burden of showing a prima facie case of obviousness.
We reject Anacor’s argument that the Board violated
the APA or due process by adopting a new theory of
obviousness not presented in the petition. Unlike in In re
NuVasive, Inc., 841 F.3d 966 (Fed. Cir. 2016), on which
Anacor relies, the Board’s final written decision was
based on the same combination of references—Austin and
Brehove—and the same series of inferences that the
petition proposed.

(...)

We also reject Anacor’s argument that the Board improperly
relied on new evidence to which Anacor did not
have an opportunity to respond. Anacor argues that the
Board improperly cited two references—Mertin and
Segal—that were not cited in the petition. There is,
however, no blanket prohibition against the introduction
of new evidence during an inter partes review proceeding.
In fact, “the introduction of new evidence in the course of
the trial is to be expected in inter partes review trial
proceedings and, as long as the opposing party is given
notice of the evidence and an opportunity to respond to it,
the introduction of such evidence is perfectly permissible
under the APA.” Genzyme, 825 F.3d at 1366; see also
Novartis AG v. Torrent Pharm. Ltd., 853 F.3d 1316, 1325–
26 (Fed. Cir. 2017) (finding no APA violation because
patent owner was not “surprised” where a reference was
discussed in patent owner’s response, in depositions, and
at the hearing, because “it is quite clear that [the patentee]
had more than sufficient notice and opportunity to be
heard on [the reference’s] potential relevance”).

In addition, the petitioner in an inter partes review
proceeding may introduce new evidence after the petition
stage if the evidence is a legitimate reply to evidence
introduced by the patent owner, or if it is used “to document
the knowledge that skilled artisans would bring to
bear in reading the prior art identified as producing
obviousness.” Genzyme, 825 F.3d at 1369 (quoting Ariosa
Diagnostics v. Verinata Health, Inc., 805 F.3d 1359, 1365
(Fed. Cir. 2015)).8
It was not improper for the Board to cite Segal and
Mertin (along with Nimura) as evidence of the knowledge
that a skilled artisan would bring to bear in reading
Austin and Brehove, even though those references were
not cited in the petition. Anacor argues that Segal, Mertin,
and Nimura “surfaced for the first time in Petitioner’s
Reply,” but that is not so. Anacor discussed both Nimura
and Segal in its patent owner’s response and related
submissions; indeed, Anacor spent three pages of its
patent owner’s response addressing Segal. For that
reason, it was not improper for the Board to rely on those
references to show what a person of skill in the art would
believe about whether a compound effective against a
yeast such as C. albicans would be likely to be effective
against a dermatophyte.


Also



Anacor next argues that the Board improperly shifted
the burden of proof by requiring the patent owner to
disprove obviousness. Relying on In re Magnum Oil Tools
International, Ltd., 829 F.3d 1364 (Fed. Cir. 2016), Anacor
contends that the record provides no basis to conclude
that tavaborole’s activity against dermatophytes would be
expected and that, in adopting the petitioner’s position
without supporting evidence, the Board necessarily shifted
the burden of proof to Anacor.
Unlike in In re Magnum, nothing in the Board’s final
written decision suggests that the Board improperly
shifted the burden to the patent owner to disprove obviousness.
To the contrary, the Board expressly and repeatedly
stated that it was the petitioner’s burden to
“show[] by a preponderance of the evidence that claims 1–
12 of the ’521 patent are unpatentable.” Final Written
Decision, at 3; see also id. at 9, 10, 18, 22, 23, 37, 42

Notwithstanding those statements, Anacor argues
that the Board effectively shifted the burden of proof to
the patent owner because the Board’s conclusions rested
not on the petitioner’s presentation of evidence in support
of an argument, but rather on whether Anacor had sufficiently
disproved that argument. In particular, Anacor
contends that the Board failed to require proof from the
petitioner as to the mechanism of action that would lead
to the conclusion that tavaborole would kill both C. albicans
and dermatophytes, and that the Board did not
explain why the evidence that dermatophytes are usually
more sensitive than yeasts to antimycotics applies to
tavaborole.
In substance, Anacor’s argument is not that the Board
shifted the burden of proof to Anacor, but that the Board
improperly relaxed the burden on the petitioner to prove
its case. That argument, however, does not suggest that
the Board shifted the burden of proof to Anacor, but
instead is directed to the question whether there was
substantial evidence to support the Board’s finding of
obviousness.



Praxaire wins at CAFC



The outcome was that Praxaire won its appeal as to claim 9:



Praxair Distribution, Inc. (“Praxair”) appeals from the
inter partes review decision of the United States Patent
and Trademark Office Patent Trial and Appeal Board
(“the Board”) holding claim 9 of U.S. Patent 8,846,112
(the “’112 patent”) not unpatentable as obvious under 35
U.S.C. § 103 (2006).1 Praxair Distrib., Inc. v. Mallinckrodt
Hosp. Prods. IP Ltd., No. IPR2015-00529, 2016 WL
3648375 (P.T.A.B. July 7, 2016) (“Decision”). Mallinckrodt
Hospital Products IP Ltd. (“Mallinckrodt”) crossappeals
from the same decision holding, inter alia, claims
1–8 and 10–11 unpatentable as obvious. Because we
conclude that the Board did not err in its conclusions as to
claims 1–8 and 10–11, but did err with respect to claim 9,
we affirm the Board’s decision in part and reverse it in
part.



Of the review by the CAFC of a PTAB ruling:


Our review of a Board decision is limited. In re Baxter
Int’l, Inc. 678 F.3d 1357, 1361 (Fed. Cir. 2012). We review
the Board’s legal determinations de novo, In re Elsner,
381 F.3d 1125, 1127 (Fed. Cir. 2004), but we review the
Board’s factual findings underlying those determinations
for substantial evidence, In re Gartside, 203 F.3d 1305,
1316 (Fed. Cir. 2000). A finding is supported by substantial
evidence if a reasonable mind might accept the evidence
as adequate to support the finding. Consol. Edison
Co. v. NLRB, 305 U.S. 197, 229 (1938).



As to claim 9:



That does not end the inquiry, however, as we must
still consider whether claim 9 as a whole would have been
obvious to a person of ordinary skill at the time of the
invention. In assessing obviousness, the Board found that
Bernasconi taught that inhaled nitric oxide may lead to
pulmonary edema in patients with LVD, and emphasized
the “need for careful observation and intensive monitoring
during [nitric oxide] inhalation” in patients with LVD.
Decision, 2016 WL 3648375, at *13. Nonetheless, the
Board held that Bernasconi did not render claim 9 obvious
for two reasons, both of which we reject.
First, in addressing the differences between the prior
art and claim 9, the Board found that Bernasconi did not
“teach[] or suggest[] that treatment with [nitric oxide]
should be discontinued in pediatric patients with LVD
that experience pulmonary edema,” as required by
claim 9. Id. at *19. Rather, the Board found Bernasconi
to be “contrary to [its] interpretation of the claim language”
because Bernasconi taught “that [nitric oxide] may
be given to patients with LVD, as long as those patients
are monitored carefully during treatment.” Id. (emphasis
added). The Board’s finding is premised on an incorrect
reading of claim 9, and under the correct reading Bernasconi
is not “contrary to” claim 9. The Board conflated
excluding a patient with LVD from nitric oxide treatment
and discontinuing nitric oxide treatment in a patient with
LVD after that patient experiences a pulmonary edema.
But claim 9 does not permit, let alone require, excluding
patients with LVD from nitric oxide treatment. Instead,
claim 9 recites that nitric oxide be given to patients with
LVD, and be discontinued if a pulmonary edema occurs.
Thus Bernasconi’s teaching that patients with LVD could
be treated with nitric oxide if carefully monitored is not
contrary to the claim language, and the Board erred by
interpreting claim 9 otherwise.
Second, the Board found “compelling” Mallinckrodt’s
evidence of secondary considerations that “patients were
not excluded” from the INOT22 study, despite the known
relationship between nitric oxide treatment and pulmonary
edema for patients with LVD. Decision, 2016 WL
3648375, at *19. The Board found persuasive the inference
that “if it were obvious to a person of ordinary skill
in the art to exclude” such patients from the study, the
researchers conducting the INOT22 study would have
done so. Id. The Board’s secondary considerations analysis
also rested on its “excluding” interpretation of claim 9.
But, because we conclude that claim 9 requires administering
nitric oxide to patients with LVD, Mallinckrodt’s
evidence of secondary considerations regarding the failure
of researchers to exclude such patients from the INOT22
study lacks sufficient nexus to the claim. See Classco, Inc.
v. Apple, Inc., 838 F.3d 1214, 1220 (Fed. Cir. 2016).

In sum, both the Board’s findings regarding the differences
between the prior art and claim 9 and its findings
on secondary considerations depended on an
incorrect interpretation of that claim, and we therefore
hold that they are not supported by substantial evidence.
See In re Smith Int’l, Inc., 871 F.3d 1375, 1384 (Fed. Cir.
2017).
We also conclude that remand is unnecessary. The
Board’s uncontested findings regarding Bernasconi render
claim 9 obvious under the proper reading of the claim.


Thursday, May 17, 2018

On ending disputes prematurely. Baseball and university professors.

On Wednesday, May 16, 2018, Jorge Ortiz of USAToday headlined that Brandon Belt of the San Francisco Giants
questioned the integrity of an umpire and wrote:


On Wednesday it was the San Francisco first baseman [Belt] who expressed his frustration, in
clear and accusatory terms against home plate umpire Doug Eddings.

Belt, who took a questionable third strike for the game’s final out in the Giants’ 6-3 loss
to the Reds, said Eddings has previously expressed a desire to end games quickly and reiterated
that notion on Wednesday.

(...)

Reds closer Raisel Iglesias got the call on a 3-2 fastball that MLB.com’s Gameday showed was clearly outside.




Giants slugger Brandon Belt questions umpire's integrity after questionable call ends game


Video of call at
https://www.mlb.com/gameday/reds-vs-giants/2018/05/16/530041#game_state=final,lock_state=final,game_tab=videos,game=530041

ESPN reported:



Belt stepped to the plate with a runner on second base and two outs in the bottom of the ninth inning
at AT&T Park. Facing closer Raisel Iglesias, Belt worked the count full before plate umpire Doug
Eddings called a third strike on a fastball just off the plate to end the game .

Afterward, Belt said there was no question he got cheated on the call and insinuated that
Eddings made it to get a matinee that lasted 2 hours, 41 minutes over with.



link: http://www.espn.com/mlb/story/_/id/23524777/brandon-belt-san-francisco-giants-raw-plate-umpire-loss-vs-cincinnati-reds

Neither post went into great detail about "how far off the plate" the pitch was. The video does suggest it was not a strike. The story was the call-out of the umpire for "ending the game" prematurely.

Also of possible relevance to ending the game prematurely is the case Kenny v. Denbo, CA3, No. 17-2342, which involves themes of plagiarism, intellectual property, Blackboard software, and arbitration.

The short description given by CA3:


Adjunct Professor Robert Kenny substituted for Professor Susan Denbo while she was
on sabbatical. After an arbitration, he was suspended for borrowing her syllabus. Kenny’s
borrowing resulted from an excusable misunderstanding. Only later did evidence come out
that Denbo had passed along that syllabus specifically for the adjunct to use. But the unavailability
of certain evidence at the arbitration does not justify rescinding his settlement.



Of "ending the game prematurely," CA3 wrote of the arbitration:


After Rider’s opening statement, and ten minutes into the Union’s opening, the arbitrator
cut off the Union’s lawyer and held a sidebar conference
. When the Union’s lawyer
returned from that conference, he relayed to Kenny and to the Rider faculty’s Union representative
that the arbitrator “wanted to see a settlement,” and “gave a broad outline” of
the sort of agreement the arbitrator had in mind. DA 277. According to the Union’s lawyer,
the arbitrator felt that any settlement “needed to include [Kenny’s] suspension.” Id.
The Union’s lawyer came back to Kenny with a proposed settlement and presented it
as a fait accompli
. Kenny signed it. As part of the settlement, he apologized in writing to
Denbo and accepted a suspension for the fall of 2012. Neither side admitted wrongdoing.
Since then, Rider has not offered Kenny any teaching assignments. When Kenny applied
for unemployment compensation, Rider told the state authorities that Kenny had been suspended
for misconduct. So his application was denied.



Of plagiarism and intellectual property, CA3 wrote



Denbo sincerely believed that Kenny’s conduct amounted to
plagiarism, so her statement was not knowingly false. And her mistake about Kenny’s permission
does not amount to reckless disregard of the truth. See id. at 777. She did not give
the syllabus directly to him and was not completely unreasonable in believing that passing
it along to Sprotzer did not authorize verbatim copying. That is particularly true because
the Collective Bargaining Agreement recognized syllabi as intellectual property. No reasonable
juror could find otherwise. So the statements are privileged, not libelous



Plagiarism is copying (basically anything) without attribution. Whether or not the the Agreement recognized
syllabi as intellectual property is not relevant to the charge of plagiarism (AND there is no federal/state cause of action
for "plagiarism" AND see below about custom and practice at this school, Rider University).
CA3 did not mention who was the owner/author of the syllabi intellectual property. One might
infer, in context, that the professor owns the intellectual property of the syllabus because of the Agreement, but otherwise one might be
in a "work for hire" context. One might also suspect that there is a lot of copying of syllabi going on.

Of Blackboard, CA3 wrote:



Kenny also visited Rider’s Blackboard website, where faculty post course materials,
and downloaded a copy of the syllabus from Denbo’s web page. Denbo’s Blackboard settings,
which were not the default, let guests access her other course materials as well, including
student resources and assignments. But Kenny did not download or share them. He
tweaked the syllabus’s grading scale, but otherwise kept the readings, sequence, and assignments
verbatim. Then he uploaded the syllabus to the spring 2012 course module

(...)

Nonetheless, Denbo was “outraged!!!!!” by all this. DA 86. In a series of emails to
Rider administrators, she accused Kenny of “EXTREME unethical behavior,” fuming that
he had accessed “MY ENTIRE BLACKBOARD!!!” using the guest access permitted by
her Blackboard privacy settings. DA 99. Denbo also fulminated that Kenny’s syllabus “is
IDENTICAL to my syllabus and references all of my Blackboard materials.” Id. In followup
emails, she continued her tirade, deploying such punctuation-peppered interjections as
“UGH!!!!” and “REALLY?????????” DA 102, 105. Even though she conceded that “he
assured me that he had not posted anything yet,” she suggested that Kenny never teach at
Rider again. DA 99-100



Somewhat related to the Rutgers/San Filippo case (but with a different outcome):


Rider acceded to Denbo’s request. For the first time at Rider (as far as we know), an adjunct professor was
disciplined for using a syllabus given to him by his department chair for a course that he
was hired to substitute teach. As the Union grievance officer testified, in his thirty-eight
years at Rider, he had never seen syllabi posted with attribution. And Sprotzer conceded
that he had never heard of any university where adjuncts were given syllabi but needed to
seek further permission to use them. App. 315-16. He also admitted that Rider developed
its unwritten policy against such borrowing only after Kenny’s arbitration.



[The San Filippo case involved 14th Amendment issues. See

Flipping Filippo, Batman, Gunasekera files federal suit against Ohio U./officials
]

Initially, Kenny's defense related to his access using Blackboard:


As the Union’s letter explained, Kenny had “reasonabl[y] but inaccurate[ly] assum[ed]”
that, because Denbo made her course materials available to guests on Blackboard, she had
given implied permission to use them. DA 61. The Provost rejected these arguments and
sustained the discipline


Of the summary judgment on libel:


The District Court arguably erred in finding
that Denbo’s statements were mere opinion rather than factual. But “[w]e can affirm
the District Court’s grant of summary judgment on any basis supported by the record.”
United States ex rel. Spay v. CVS Caremark Corp., 875 F.3d 746, 753 (3d Cir. 2017)



Of the discovery issue, CA3 wrote


The Union
was not allowed to depose witnesses, but it asked for all materials collected during the
Provost’s investigation, including correspondence, emails, and Blackboard records



The interpretation of this was that if emails were not collected, they were not within the scope.
By this logic, the recipient of a discovery request could choose not to collect certain emails during
the investigation, and they would not fall within the scope of discovery.

CA3 wrote of duty to disclose:


But Kenny has produced no evidence that could justify a jury in finding a misrepresentation
here. Not turning over the three emails in question could amount to one only if Rider had
an obligation to do so. And while New Jersey does recognize that “[s]ilence in the face of
a duty to disclose may constitute a fraudulent concealment,” it imposes such a duty only in
limited circumstances. See United Jersey Bank v. Kensey, 704 A.2d 38, 43 (N.J. Super. Ct.
App. Div. 1997). This is not a case involving—at least as between Kenny and his employer—“fiduciary
relationships such as principal and agent.” Id. at 44.

Nor are settlement negotiations the kind of “transactions which in their essential nature,
are intrinsically fiduciary, and necessarily call for perfect good faith and full disclosure.”

Id. (internal quotation marks and alteration omitted). In other circumstances, the New Jersey
courts have declined to find a quasi-fiduciary relationship when the parties act “at armslength,
... in their own interest,” and stand in “essentially adversarial” positions. Id. at 44-
45 (discussing lender-borrower negotiations). All of these qualities are present in a labor
arbitration conducted, like this one, between sophisticated parties represented by counsel.




**Separately


Professor who punished plagiarists fired over FERPA>



Newark Star-Ledger does Rutgers plagiarism case on 4 Dec 2011


Trademark cancelled for failure to respond in discovery

**See especially


Harsh penalty dealt to student copying from wikipedia


which references the PatentlyO post
Plagiarism Actions

as to text


(3) “failing to consider Dr. Adames’ [own] plagiarism” (he had copied portions
of his syllabus from another professor without attribution);



AND


We may affirm the trial court's judgment after a bench trial on any basis in the record,
regardless of whether the trial court relied on that basis or whether the trial court's reasoning was
correct. Northwestern Memorial Hospital v. Sharif, 2014 IL App (1st) 133008, ¶ 25. We affirm
the trial court's judgment in favor of defendant on plaintiff's breach of contract action, not on the
grounds stated by the court (which were based solely on plaintiff's failure to appeal her dismissal
to the dean of academic affairs and on the lack of proof of damages) but rather on plaintiff's
failure to meet her heavy burden of proving that defendant acted in an arbitrary, capricious, or
bad-faith manner by dismissing her without any discernible rational basis.




concerning Drobetsky v. Chicago School of Prof. Psych.

Saturday, May 12, 2018

Plagiarism in a high school yearbook in Pensacola?



From the Pensacola News Journal article titled Escambia High rewrites yearbook page on school's racial history, claims student plagiarized :



Escambia High School administrators removed and rewrote a page from this year's student yearbook that contained information about the school's origin and race-related issues, claiming the student who wrote the page plagiarized information from the internet.

But the student, 18-year-old yearbook co-editor Sasha Slack, believes the school rewrote the page because they are "trying to change the history of Escambia High School because they’re too ashamed to admit that our school was founded as an all-white school."

In the 60th anniversary edition of the yearbook, Slack wrote about the school's pre-segregated era and the on-campus race riots of 1976. The senior said she researched multiple websites and wrote a long paragraph titled "Escambia's Past" in her own words, which the school claims to be false. [emphasis added]

(...)

Murphy said that ultimately, he did not want Slack's original writing to reflect poorly on the school.

"I just feel that we cannot allowed plagiarized work to be presented in a journalism class," Murphy said. "That is the issue here. That's the only issue here, is the plagiarism." [emphasis added]



There are several issues here

was there plagiarism? [copying without attribution]

if no plagiarism, was the motivation of the school an unfavorable portrayal in the yearbook? Was the portrayal false?

was the plagiarism claim a pretextual makeweight argument or a reasonable response to a concern about bad journalism?

Rensselaer Polytechnic Institute sues Amazon in ND NY over US Patent 7,177,798


The co-plaintiff is the exclusive licensee Dynamic Advances, a Delaware corporation whose principal
place of business is located at 1345 Avenue of the Americas, 46th Floor, New York, NY.

Paragraph 41 of the complaint refers to patent citation:



The ’798 Patent has been repeatedly cited in subsequent patent
applications filed by leading technology companies. The ’798 Patent, its published
application, or other patents within the same family, have been cited in patent
applications filed by Hewlett-Packard, Microsoft, IBM, Sony, Google, and Apple.


Complaint available at:
https://regmedia.co.uk/2018/05/11/alexapatentcomplaint.pdf

Altaire wins on evidentiary issues at CAFC; a split vote on standing, and injury-in-fact


The case is nominally an appeal of a PTAB decision:


Appellant Altaire Pharmaceuticals, Inc. (“Altaire”)
sought post-grant review of claims 1–13 (“the Asserted
Claims”) of Appellee Paragon Bioteck, Inc.’s (“Paragon”)
U.S. Patent No. 8,859,623 (“the ’623 patent”). The U.S.
Patent and Trademark Office’s Patent Trial and Appeal
Board (“PTAB”) issued a final written decision determining
that Altaire failed to prove that the Asserted Claims
were unpatentable for obviousness over two production
lots of Altaire’s phenylephrine hydrochloride ophthalmic
solution products, Lots #11578 and #11581,


There is much more going on here; from the dissent:


The undisputed facts are these: In 2011, Altaire and
Paragon entered into an agreement to pursue U.S. Food
and Drug Administration (“FDA”) approval for Altaire’s
phenylephrine hydrochloride products (the “Agreement”).
By its terms, the Agreement terminates on May 30, 2021.
See Joint Appendix (“J.A.”) 1909. Subsequently, a dispute
arose between the parties, which apparently led Altaire to
file two lawsuits in federal court in the Eastern District of
New York. In the first suit, Altaire Pharmaceuticals, Inc.
v. Paragon BioTeck, Inc., Case No. 2:15-cv-02416
(E.D.N.Y.) (“the breach of contract suit”), Altaire alleges
that Paragon breached the Agreement by, among other
things, disclosing Altaire’s confidential and proprietary
product information in its patent application and in its
resulting U.S. Patent No. 8,859,623 (“the ’623 patent”).
See Complaint and Jury Demand at 7 (No. 2:15-cv-02416)
(E.D.N.Y. April 28, 2015). P



BUT the issues decided are evidentiary in nature.


There was an initial standing issue, which was a basis for the dissent
opinion; the majority noted:


We recently “established the legal standard for
demonstrating standing in an appeal from a final agency
action,” including “the burden of production[,] the evidence
an appellant must produce to meet that burden[,]
and when an appellant must produce that evidence.”
Phigenix, Inc. v. Immunogen, Inc., 845 F.3d 1168, 1172
(Fed. Cir. 2017) (footnote omitted). We explained that
“[a]n appellant’s obligation to establish injury in fact
remains firm even though it need not meet all the normal
standards for redressability and immediacy when, as
here, a statute provides that appellant with a right to
appeal.” Id. at 1172 n.2 (internal quotation marks and
citation omitted); see 35 U.S.C. § 141(c).

(...)

While we recognize that “[a] claim is not ripe for adjudication
if it rests upon contingent future events that may
not occur as anticipated, or indeed may not occur at all,”
Texas v. United States, 523 U.S. 296, 300 (1998) (internal
quotation marks and citation omitted), we conclude that,
under these circumstances, Altaire’s injury is inevitable.
Therefore, Altaire has satisfied its burden of production
by producing sufficient evidence that the threat of infringement
litigation is an injury that is “real” and “imminent.”
Prasco, 537 F.3d at 1339.

Having determined that Altaire faces imminent injury,
we next must determine whether that injury is concrete
and particularized. See Spokeo, 136 S. Ct. at 1548
(“Particularization is necessary to establish injury in
fact . . . .”); id. (“Concreteness . . . is quite different from
particularization.”).




Graver Tank is cited:


First, § 42.65(b) does not require that the affidavit
corroborating the technical test or data be submitted by
an expert. Cf. Graver Tank & Mfg. Co. v. Linde Air
Prods. Co., 339 U.S. 605, 609 (1950) (stating that, in the
context of the doctrine of equivalents, “[p]roof can be
made in any form,” including “through testimony of
experts or others versed in the technology” (emphasis
added)).



Of evidentiary issues:


Although the PTAB “has broad discretion to regulate
the presentation of evidence,” Belden, 805 F.3d at 1081,
that discretion is not without limits, see Ultratec, Inc. v.
CaptionCall, LLC, 872 F.3d 1267, 1274 (Fed. Cir. 2017)
(stating that “[t]he agency does not have unfettered
discretion in [evidentiary] matters”). The PTAB’s decision
to assign no weight to Mr. Al Sawaya’s testimony was an
abuse of discretion. See id. at 1275 (holding that the
PTAB “abused its discretion when it refused to admit and
consider . . . trial testimony”); cf. Aqua Prods., Inc. v.
Matal, 872 F.3d 1290, 1325 (Fed. Cir. 2017) (en banc)
(plurality opinion) (“[A]n agency’s refusal to consider
evidence bearing on the issue before it is, by definition,
arbitrary and capricious within the meaning of 5 U.S.C.
§ 706, which governs review of agency adjudications.
That means that the agency must take account of all the
evidence of record, including that which detracts from the
conclusion the agency ultimately reaches.” (citations
omitted)).
(...)
On remand, the PTAB must consider Mr. Al Sawaya’s testimony when
evaluating the reliability of the TMQC-247 and optical
rotation test data.



As to evidence in a reply:


After Paragon unexpectedly challenged Altaire’s
TMQC-247 test data for failure to comply with § 42.65(b)
in its Patent Owner Response, see J.A. 1112–15, Altaire
submitted its Reply, appending additional information on
the TMQC-247 test, see J.A. 1418–25, 1505–606. This
included Exhibits 1027 and 1028. See J.A. 1505–32.
Similar to the Second Al Sawaya Declaration, Altaire
properly “respond[ed] to [those] arguments raised in
[Paragon’s Patent Owner R]esponse” by submitting additional
evidence demonstrating the reliability of the
TMQC-247 testing method. 37 C.F.R. § 42.23(b); see 5
U.S.C. § 556(d); see also Belden, 805 F.3d at 1078. To the
extent Paragon wished to contest this additional evidence,
the PTAB could have permitted Paragon to file a surreply.
See Belden, 805 at 1081.
In light of Paragon’s past reliance on the TMQC-247
test data, we conclude that the PTAB abused its discretion
by “refus[ing] to consider evidence” regarding the
reliability of the TMQC-247 testing method. Aqua, 872
F.3d at 1325 (citation omitted); see Ultratec, 872 F.3d at
1275. On remand, the PTAB shall consider all relevant
TMQC-247 information in determining whether Altaire
satisfied the requirements of § 42.65(b) and, if it did,
whether the TMQC-247 test data render obvious the
Asserted Claims.



Some odd arguments:



Finally, regarding the optical rotation test, the PTAB
determined that Paragon “presented sufficient evidence to
challenge the accuracy of estimating enantiomer purity
based on the specific rotation,” such that it “[was] not
persuaded that [Altaire]’s optical-rotation data amount to
a preponderance of the evidence to show that Altaire’s
[p]roduct[s] meet[] the chiral-purity limitations of the
[Asserted C]laims.”
J.A. 19, 20. As with the TMQC-247
test data, Paragon relied upon this optical rotation test
data before the FDA. See J.A. 783–91. Indeed, the ’623
patent itself recognizes that the optical rotation test can
be used to determine chiral purity.
See ’623 patent col. 4
ll. 33–34.

Nevertheless, the PTAB rejected the data, stating
that, “for the optical rotation data, as for the [TMQC-247]
data, [Altaire] has not provided any affidavit in compliance
with . . . § 42.65(b).” J.A. 19. However, as explained
above, see supra Section II.B–C, the PTAB abused its
discretion by refusing to consider Mr. Al Sawaya’s testimony
and the additional information on the TMQC-247
test data. To the extent the PTAB’s decision to reject as
unpersuasive the optical rotation test data rested upon
these erroneous determinations, the PTAB must reconsider
the reliability of the optical rotation test data pursuant
to § 42.65(b) on remand.




The dissent as to standing:


I start from the premise that the standing issue in
this case turns entirely on the pending litigation in the
Eastern District of New York. I say that because, although
both Altaire and the majority point to the Agreement’s
2021 termination date, Appellant’s Br. 47–48,
Majority Op. at 12, I am unable to see how the fact that
the Agreement is scheduled to terminate in 2021 supports
standing at this point. Put most simply, what we have is
a situation in which the parties to a contract that is due to
terminate in approximately three years are in a dispute.
At the same time, in view of the terms of the Agreement,
Altaire cannot infringe the ’623 patent while the Agreement
is in effect. These circumstances, it seems to me,
come nowhere near providing Altaire with grounds for
claiming that it is subject to imminent harm. Timing is
important for a showing of imminence, or immediacy.

The longer the time between when suit is initiated and
when potential infringement may occur, “the more likely
the case lacks the requisite immediacy.” Sierra Applied
Scis., Inc. v. Advanced Energy Indus., Inc., 363 F.3d 1361,
1379 (Fed. Cir. 2004).





***In passing, this is a case about enantiomers.

AIDS HEALTHCARE FOUNDATION loses appeal at CAFC


An attempt by AIDS HEALTHCARE FOUNDATION at a DJ against Gilead failed:


Healthcare argued that in view of the lengthy time
consumed by litigating patent validity, such litigation
needed to start well in advance of expiration of the fiveyear
exclusivity period. See, e.g., AHF Br. 5; Dist. Ct. Op.
at *4–5. Healthcare filed this declaratory action in January
2016, two months after the FDA approved Genvoya®—the
first TAF-containing product to receive FDA
approval.



The outcome


This appeal is from the dismissal of a declaratory
judgment action filed by AIDS Healthcare Foundation,
Inc. (“Healthcare” or “AHF”) against Gilead Sciences, Inc.
et al. (“Defendants”) in the United States District Court
for the Northern District of California.1 On appellate
review, we conclude that this action does not meet the
requirements of the Declaratory Judgment Act.




The CAFC began its discussion:



Exercise of the Constitution’s judicial power is limited
to actual cases and immediate controversies. Muskrat v.
United States, 219 U.S. 346, 356 (1911). When this constitutional
requirement is not met, a court has no authority
to decide the issues presented, whatever the
“convenience and efficiency” of such judicial action.
Hollingsworth v. Perry, 133 S. Ct. 2652, 2661 (2013)
(quoting Raines v. Byrd, 521 U.S. 811, 820 (1997)); see
Muskrat, 219 U.S. at 356 (“[U]nless [the exercise of the
judicial power] is asserted in a case or controversy within
the meaning of the Constitution, the power to exercise it
is nowhere conferred.”).



Some of the issues in this case


The existence of a patent, without more, does not create
a case of actual controversy. See Prasco, LLC v.
Medicis Pharm. Corp., 537 F.3d 1329, 1339 (Fed. Cir.
2008) (“[J]urisdiction generally will not arise merely on
the basis that a party learns of the existence of a patent
owned by another or even perceives such a patent to pose
a risk of infringement, without some affirmative act by
the patentee.” (quoting SanDisk Corp. v. STMicroelectronics,
Inc., 480 F.3d 1372, 1380–81 (Fed. Cir. 2007))).

Healthcare presents several additional arguments for
declaratory jurisdiction, including that (1) Healthcare is
an indirect infringer of the TAF patents based on its
requests to potential producers to provide the patented
products; (2) Gilead’s non-response to Healthcare’s request
for a covenant not to sue created a present controversy;
and (3) public policy favors invalidation of invalid
patents and thus the testing of “weak” patents. The
district court, receiving all of Healthcare’s arguments,
correctly held that the declaratory judgment criteria were
not met.



No immediacy here:


Healthcare argues that it meets this requirement because
of the lengthy time required for patent litigation,
such that an immediate start is needed. However, the
time consumed by litigation of a speculative future controversy
does not provide the “immediacy and reality”
required for declaratory judgment actions
; nor is a declaratory
tribunal precluded from providing expedited relief
when such is warranted. In this case, where there is no
present infringement, no threat of or possibility of infringement
litigation, and no meaningful preparation to
infringe, the “immediacy and reality” criteria are not met.
See, e.g., Prasco, 537 F.3d at 1338–39

(...)

The district court observed the absence of evidence of
preparation to produce a product covered by any of the
TAF patents, and found “significant uncertainty about the
nature of any hypothetical product.” Dist. Ct. Op. at *5.
The uncertainty of whether future infringement might
occur at all weighs against the immediacy and reality
requirement of declaratory action. Matthews, 695 F.3d at
1328–29. In addition, precedent illustrates that the mere
possibility of future infringement does not meet the
immediacy and reality criteria, for “[a] party may not
obtain a declaratory judgment merely because it would
like an advisory opinion,” id. at 1329 (quoting Cat Tech,
528 F.3d at 881). For example, in Benitec Australia, Ltd.
v. Nucleonics, Inc., 495 F.3d 1340, 1349 (Fed. Cir. 2007),
this court held that a representation that the declaratory
plaintiff “expects to begin work shortly” on “potentially
infringing” activities was of insufficient immediacy to
support a declaratory action.



Also


Liability for induced infringement requires that some
other entity is directly infringing the patent. Power
Integrations, Inc. v. Fairchild Semiconductor Int’l, Inc.,
843 F.3d 1315, 1331 (Fed. Cir. 2016).



Fina was distinguished


In Fina Research, the declaratory plaintiff was a foreign
entity that was manufacturing and selling an ingredient
of drilling mud abroad; the holder of United States
patents on compositions containing the drilling mud had
sent letters to the foreign producer, stating that the
patentee would sue for infringement if the ingredient
were introduced in the United States. The court held that
such a direct threat of suit against an existing product
and its producer established declaratory jurisdiction.
Fina Research, 141 F.3d at 1482–84; see also SanDisk,
480 F.3d at 1382 (describing how the presentation of “a
thorough infringement analysis” and “element-byelement”
product analyses created a case or controversy
supporting declaratory judgment jurisdiction). In contrast,
here the record does not refer to threats of litigation
on importation of existing product, or even an identification
of any product whose importation may violate Gilead’s
patent rights. No such TAF-containing products are
reported to exist.



As to policy arguments:


Healthcare argues that public policy is served by invalidation
of invalid patents, and thus supports immediate
challenge to the “weak” TAF patents. Yet the HatchWaxman
Act is already a balance of several policy interests,
seeking to preserve the patent incentive to invent
new drugs, while enabling validity challenge by ANDA
filers before actual infringement occurs. Andrx Pharm.,
Inc. v. Biovail Corp., 276 F.3d 1368, 1371 (Fed. Cir. 2002).
The present policy reflects a balance of several factors
and public interests; any policy change would require reexploration
of all aspects. Healthcare’s proposal of a
change in policy to facilitate challenge to drug patents
would warrant legislative consideration, not departure
from precedent. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348,
1358 (2018) (“Policy arguments are properly addressed to
Congress, not this Court.”)


Thursday, May 10, 2018

2018 article in Slate re-cycles "secret" inventions


Back in 2009, IPBiz had a post titled
The "patent control policy" of World War II and US 2,852,687
which in part related to "secret" patents
and included the text:


Fortunately for [Vannevar] Bush, however, U.S. patent law had been specifically amended so as to permit patent applications to be ordered held in secret in extraordinary circumstances. The original legislation had been passed during World War I to allow patents with military implications to be declared “secret” during wartime, and in 1940 and 1941 the statute had been revised to apply during peacetime as well and to have stiffer penalties associated with the violation of secrecy orders (the original penalty having been simply loss of patent title).33 The result of this legislative action was Public Law No. 700, a bill that allowed the Patent Office (via the authority of the Commissioner of Patents) to declare patent applications secret, preventing both their publication and access in the United States and
also blocking their filing outside of the country. The question of whether the application would be granted was put on hold until the secrecy order had been lifted. If the patent was eventually granted, the inventor could then work out problems of interference with subsequently granted patents and could sue for compensation if the government had used the patent in the interim.



Fast forward to the year 2018, and ARVIND DILAWAR has a post at Slate titled The U.S. Government’s Secret Inventions which included the text


Invention secrecy in the U.S. dates back to at least the 1930s, but it really took off in the ’40s, when the development of nuclear weapons was shrouded in classification.



See also the post in the July 2009 issue of Inventors Digest The government is classifying more innovations as secret in the name of national security.

The 2018 article in Slate is treading old ground